E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
PARKINSON´S DISEASE |
ENFERMEDAD DE PARKINSON |
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E.1.1.1 | Medical condition in easily understood language |
PARKINSON´S DISEASE |
ENFERMEDAD DE PARKINSON |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10061536 |
E.1.2 | Term | Parkinson's disease |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To study the efficay of gabapentin versus placebo in the disorder of impulse control in the Parkinson´s disease, using for its evaluation the Questionnaire for Impulsive-Compulsive Disorder in Parkinson´s Disease. |
Estudiar la eficacia de la gabapentina versus placebo en el Trastorno de control de impulso (TCI) de la enfermedad de Parkinson (EP), mediante la evaluación de su gravedad usando el cuestionario Score in the Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease - Rating Scale (QUIP-RS). |
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E.2.2 | Secondary objectives of the trial |
1.To verify if the treatment with gabapentin leads to changes in the Parkinson´s motor state.
2.To evaluate if gabapentin modifies the anxiety and depression associated to the disorder of impulse control in the Parkinson´s disease.
3.To analyze if gabapentin has any other effect on the motor aspects related to the Parkinson´s Disease.
4.To study if the treatment with gabapentin associates to apathy.
5.To determine the effect of gabapentin versus placebo in the patient´s quality of life.
6.To verify the security and tolerability of gabapentin, evaluated by the presence of secondary effects.
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1. Comprobar si el tratamiento con gabapentina induce cambios en el estado motor parkinsoniano.
2. Estudiar si la gabapentina modifica la ansiedad y depresión, que frecuentemente se asocian con el TCI en la EP.
3. Analizar si la administración de gabapentina tiene efecto sobre otros aspectos no motores relacionados con la EP.
4. Estudiar si el tratamiento con gabapentina se asocia con apatía (como rasgo de conducta opuesto a la impulsividad)
5. Determinar el efecto de gabapentina versus placebo en la calidad de vida de los pacientes con TCI.
6. Comprobar el grado de seguridad y tolerabilidad de la gabapentina, evaluada por la presencia de efectos secundarios, en esta población de pacientes.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1.Subjects with Parkinson´s disease treated with dopaminergic drugs.
2.Subjects that present disorder of impulse control according to the validated diagnostic criteria (parkinson´s Disease Impulsive-compulsive Disorders diagnostic interview; Weintraub et al, Mov Disror 2009;30:1461-7) who after the gradual reduction of the dopaminergic treatment continue presenting disrorder of the impulse control.
3.Older than 18 years old.
4.Signed informed content.
5.Women of childbearing age should get a negative pregnancy test in serum or urine at the screening visit, and accept the use of adequate contraception for at least 14 days before the first dose of study drug to the 14 days after the last. Postmenopause is defined as the absence of menstruation during the year prior to study entry.
6.In men with couples of childbearing age, accept the use of contraceptive methods.
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1.Presentar EP tratada con fármacos dopaminérgicos
2.Presentar TCI según los criterios diagnósticos validados (Parkinson's Disease Impulsive-Compulsive Disorders diagnostic interview; Weintraub et al, Mov Disord 2009; 30:1461-7) que tras la reducción gradual del tratamiento dopaminérgico (ver diseño) continúen presentando TCI. Aquellos pacientes en los que persista el TCI (si bien su intensidad puede haberse reducido como consecuencia de la reducción dopaminérgica) cuando alcancen la reducción significativa en la escala UPDRS motora, o presenten un agravamiento en las complicaciones motoras (fluctuaciones y/o disquinesias) según la UPDRS-IV, serán los sujetos considerados para la aleatorización al tratamiento con gabapentina o placebo.
3.Ser mayor de 18 años.
4.Firmar el consentimiento informado.
5.Las mujeres en edad fértil deberán obtener un resultado negativo en la prueba de embarazo en suero ó en orina en la visita de selección, y aceptar el empleo de métodos anticonceptivos adecuados al menos 14 días previos a la primera dosis del fármaco del estudio hasta los 14 días siguientes a la última. Se define la postmenopausia como la ausencia de menstruación durante el año anterior a la entrada en el estudio.
6.En varones que tengan pareja en edad fértil, aceptar el empleo de métodos anticonceptivos.
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E.4 | Principal exclusion criteria |
1.Subjects with psycosis (hallucination, delirium, etc).
2.Subjects with dementia.
3.Subjects treated through deep cerebral stimulation for the Parkinson´s Disease or any other cerebral intervention.
4.Subjects with renal failure.
5.Patients treated with antiepileptic drugs.
6.Patients treated with atypical neuroleptic drugs.
7.Subjects with physical or psychical inability to participate in the study.
8.Pregnant women or under lactation.
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1.Pacientes con psicosis (alucinaciones, delirio, etc)
2.Pacientes con demencia
3.Pacientes tratados mediante estimulación cerebral profunda para la EP o con otras intervenciones cerebrales
4.Pacientes con fallo renal
5.Pacientes en tratamiento con antiepilépticos
6.Pacientes en tratamiento con neurolépticos atípicos.
7.Pacientes con incapacidad física o psíquica para participar en el ensayo
8.Pacientes embarazadas o en fase de lactancia
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E.5 End points |
E.5.1 | Primary end point(s) |
Score in the Questionnaire for Impulsive-Compulsive Disorders in Parkinson´s Disease- Rating Scale. |
Puntuación en la escala que evalúa la gravedad del TCI en la EP (Score in the Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease - Rating Scale (QUIP-RS). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
EVERY VISIT |
EN CADA VISITA |
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E.5.2 | Secondary end point(s) |
1. Score in the Unified Parkinson´s Disease Rating Scale, motor section that evaluates the degree of parkinsonism (UPDRS-III).
2. Score in the Unified Parkinson´s Disease Rating Scale, motor complications section, which evaluates motor fluctuations and dischinesia (UPDRS-IV).
3. Score in the PDQ39 (quality of live).
4. Score in the Parkinson´s Disease Rating Scale daily life activities section (UPDRS-II).
5. Score in the Starkstein apathy scale and impulsivity in the Barrat scale.
6. Score in the Hamilton ansiety and depression scale (HADS).
7. Presence of motor symptom detected in the scale of Parkinson´s Disease Nonmotor Symptoms Questionnaire (NMSQ).
8. Score in the sleepiness scale of Epworth.
9. Incidence of secondary effects in patients treated with gabapentin and placebo.
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1. Puntuación en la Unified Parkinson’ disease Rating Scale sección motora (UPDRS-III) que evalúa el grado de parkinsonismo (incapacidad motora)
2. Puntuación en la Unified Parkinson’ disease Rating Scale sección de complicaciones motoras (UPDRS-IV) que evalúa fluctuaciones motoras y disquinesias
3. Puntación en la escala PDQ39 que evalúa calidad de vida en la EP
4. Puntuación en la Unified Parkinson’ disease Rating Scale sección actividades de la vida diaria (UPDRS-II)
5. Puntuación en las escalas de apatía de Starkstein y de impulsividad de Barrat
6. Puntuación en la escala de ansiedad y depresión de Hamilton (HADS)
7. Presencia de síntomas no motores detectados con la escala para la EP Nonmotor Symptoms Questionnaire (NMSQ)
8. Puntuación en la escala de somnolencia de Epworth
9. Incidencia de efectos secundarios en pacientes tratados con gabapentina y placebo.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
EVERY VISIT |
EN CADA VISITA |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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When completed the statistical analysis of all results. |
Cuando finalicen los análisis estadísticos de todos los resultados. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |